Kornimate/medical-research-clean huggingface dataset:
xp13512 vs. placebo in patients with restless legs syndrome.

Conditions: Restless Legs Syndrome

Summary: the primary objective of this trial is to assess the efficacy of xp13512 taken once daily compared to placebo for the treatment of patients suffering from restless legs syndrome (rls).

this was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of xp13512 in subjects with restless legs syndrome (rls). eligible subjects were randomized to receive 1 of 3 once daily oral doses of xp13512 1200 mg, xp13512 600 mg, or placebo. the primary study objective was to compare the efficacy of xp13512 1200 mg taken once daily for 12 weeks versus placebo. the secondary study objectives were to assess the efficacy of xp13512 600 mg taken once daily for the reatment of rls and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both xp13512 1200 mg and 600 mg.

Eligibility criteria:
inclusion criteria: * patients with primary rls, based on the international rls study diagnostic criteria. exclusion criteria: * a sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of rls; * neurologic disease or movement disorder (e.g., diabetic neuropathy, parkinson's disease, multiple sclerosis, dyskinesias, and dystonias); * abnormal laboratory results, electrocardiogram (ecg) or physical findings; * pregnant or lactating women; * women of childbearing potential who are not practicing an acceptable method of birth control.
esophageal motility and airway defenses among infants

Conditions: Infant, Premature, Diseases; Congenital Abnormalities; Perinatal Asphyxia

Summary: feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. some of these problems may be dependent on neural control and muscular function. prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear.

with the aid of small clinical research funding from the niddk, in this proposal, we have developed methods to safely evaluate foregut motility in relation to breathing among high risk infants. we are using simultaneous esophageal motility studies, swallowing and respiratory measurements in this evaluation.

Eligibility criteria:
inclusion criteria: prematurely born infants, infants with congenital foregut anomalies, infants with perinatal asphyxia, ability to maintain vital signs at study, exclusion criteria: no contraindication to enteral feeding

Keywords: esophageal airway
autovpap versus vpap; assessment of sleep and ventilation

Conditions: Chest Wall Disorder; Neuromuscular Disease

Summary: the aim of the study is to compare the effects of a modified form (autovpap) of the vpap non-invasive ventilator versus standard vpap ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).


Eligibility criteria:
inclusion criteria: * patients aged 18-80 years * nocturnal hypoventilation (nocturnal peak transcutaneous pco2 \> 6.5 kpa when breathing spontaneously) with * congenital neuromuscular disease (eg. duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty) * recruited from 1300 patients attending royal brompton hospital lind ward ventilator clinic. * all patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a vpap model eg. bipap harmony, breas pv403. * able to understand treatment and protocol exclusion criteria: * unstable respiratory failure (pao2 \ 8.0 kpa, * uncontrolled heart failure or arrhythmia * moderate or severe bulbar weakness. * unable to understand treatment or protocol
evaluation of mirnas in endometriosis

Conditions: Endometriosis; Endometriosis Fertility; Endometriosis-related Pain

Summary: we therefore propose a research project based on the prospective evaluation of mirnas (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical pma) in the endometriosis expert center hospital.


Eligibility criteria:
inclusion criteria: - patient aged 18 to 43 years old, * patient has dated and signed the consent form, * patient affiliated with the french health care system, * patients with formal endometriosis diagnosed by clinical examination and imaging or suspicion of endometriosis for which the diagnosis is a source of discrepancy between clinical and radiological data, * patient with an indication for medically assisted procreation (map) or surgery validated in cpr (in routine care), * patient who has had a pelvic mri, * patient who completed the symptom and quality of life questionnaires exclusion criteria: * pregnant patient, * patient infected with the human immunodeficiency virus (hiv), * patient with significant difficulties in reading or writing the french language, * patient with a personal history of cancer, * patient unable to comply with study and/or follow-up procedures, * patient who has objected to the collection of her data. * patient participating in another clinical research study.

Keywords: endometriosis mirna
perioperative oral steroids for chronic rhinosinusitis without polyps (crssnp)

Conditions: Chronic Rhinosinusitis; Endoscopic Sinus Surgery; Chronic Rhinosinusitis Without Polyps; Oral Steroids

Summary: while oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (crssnp) is ambiguous. despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. the aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in crs without polyps.


Eligibility criteria:
inclusion criteria: * crssnp as defined by clinical practice guideline (update) on adult sinusitis * scheduled to undergo endoscopic sinus surgery exclusion criteria: * chronic rhinosinusitis with polyps (crswnp) * aspirin exacerbated respiratory disease * cystic fibrosis * immunosuppressive states (human immunodeficiency virus, transplant) * oral steroid use within 30 days of surgery
clinical trial to evaluate the efficacy and safety of megacarti® in knee cartilage defects

Conditions: Osteoarthritis, Knee

Summary: the megacarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. the megacarti® is applied after microfracture treatment on patients with knee cartilage defects. the cartilage regeneration, which is a primary endpoint, is compared to the microfracture group through mocart evaluation. in addition, the improvement of pain and the recovery of normal range of motion are compared to the microfracture group through secondary endpoints. then, long-term follow-up study for 5 years is conducted to the experimental group.


Eligibility criteria:
inclusion criteria: 1. 19 years to 65 years 2. patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form. 3. defect: international cartilage repair society(icrs) grade iii or iv single defect chondral lesion on knee cartilage 4. patients whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms 5. knee cartilage defect size : below 10 ㎠ exclusion criteria: 1. patients who have autoimmune diseases (ex. rheumatoid arthritis) 2. patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (possible for hto surgery) 3. when screening, patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months 4. when screening, patients who took oral steroid within 1 month 5. when screening, patients who have clinically significant abnormalities in blood, serum, or urine tests 6. patients taking immunosuppressive drug, or having immune disorder 7. patients who can't take mri scan 8. patients with a history of cancer within the past five years 9. patients who have chronic renal failure, active hepatitis, or poor blood sugar control 10. bmi index : 30 ㎏/㎡ or over 11. patients who have gout or gout history in the knee 12. when screening, women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception. 13. drug and alcohol addiction / dependence or mental disorder 14. patients with risk factor for bleeding (patients taking antithrombotic drugs other than aspirin) 15. patients who have systemic or localized knee infection 16. other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial 17. patients who participated in other clinical trials within three months before screening

Keywords: knee cartilage defects microfracture megacarti cartilage regeneration
are character building lessons effective in decreasing bullying behaviors?

Conditions: Aggression

Summary: through the use of an educational intervention, the object of this study is to reduce the prevalence of bullying behaviors among fifth grade school age children. bullying behaviors promote an environment of violence , fear, and hostility. the study will arrange to present six character education lessons in the classroom of fifth grade students in a new york city public school. questionnaires will be administered to the students before and after all the lessons have been completed. questionnaires will collect information about the students self perception of their levels of misconduct, impulsivity, confidence, value of non violence, ways of handling anger, opinions of their leadership behaviors, prevalence of bullying behaviors, and indications of levels of self esteem. also, their fifth grade teachers will complete pre and post treatment student behavioral questionnaires.

this is a 2 x 2x 2 research design that will study the constructs of self esteem, leadership skills, and prevalence of bullying among a fifth grade school age population. before data collection, a letter describing the study along with an informed consent sheet, will be mailed to the student's parent/guardian. the written material will state that their child participation is not mandatory. a 48 item likert style questionnaire pre-treatment, post-treatment survey design will be administered to students. basic demographic questions will also be asked about. all fifth graders will be given questionnaires before they receive the six classroom lessons of 45 minutes duration and then after all the six lessons have been completed. lessons will be offered on a weekly basis. the fifth graders will be divided into small groups of approximately 10 individuals. the lessons will be delivered by baccalaureate nursing students in their last semester of college. the groups will be formed at the beginning and membership will remain consistent to enhance development of trust and ease of authentic communication. the lessons will be selected from the program, overcoming obstacles, a formal educational program designed to assist students to communicate well and set meaningful goals for their lives. in addition, the classroom teachers will be asked to complete a 14 item likert style pre-treatment, post-treatment, both before and after the six lessons about their opinions of each student's behaviors pattern. a statistician is a co-investigator and will identify the type of statistical analysis to be done.

Eligibility criteria:
inclusion criteria: * fifth grade elementary school students exclusion criteria: * special education students

Keywords: classroom violence, character, bullying, self esteem
the effect of child choice with accompanying parent on postoperative delirium during induction of anesthesia

Conditions: Anxiety State; Child Behavior; Postoperative Delirium

Summary: induction of anesthesia can be distressing both for children and their parents. nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs. the aim of this study will be to evaluate whether the children's or parental preference with attending parent affects on the postoperative delirium of the children or not. the delirium of the children will be assessed by the pediatric anesthesia occurrence delirium scale (paed)

anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . to minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety. although the effect of parental presence on the anxiety of children and parents was studied in various studies. whether the children's choice of parental selection affects anxiety and postoperative delirium not studied yet. in this study, we will evaluate the anxiety of children by using mypas and postoperative delirium by using paed.

Eligibility criteria:
inclusion criteria: 1. 5-12 years aged children 2. asa physical status i-ii 3. who underwent day-case surgeries in the ear nose and throat clinic exclusion criteria: 1. mentally challenged 2. deaf child 3. cerebral palsy 4. premedicated child 5. language problem 6. unco-operative 7. previous surgery or anesthesia history

Keywords: day- case surgery, anxiety children postoperative delirium
24-hour movement behaviors among normal weight, overweight and obese adults

Conditions: Overweight and Obesity

Summary: the prevalence of adults with overweight (50%) and obesity (15%) reached high number in belgium. important lifestyle behaviors, i.e. sleep, sedentary time (sb), and physical activity (pa) subdivided into light physical activity (lpa) and moderate to vigorous physical activity (mvpa), have shown an impact on overweight and obesity characteristics (e.g. adiposity). however, these behaviors have often been investigated separately. therefore, a recent shift in research emphasizes the importance of considering these behaviors as part of a 24-hour day. since these adults can benefit from an optimal 24-hour composition as part of a healthy lifestyle, it may be interesting to investigate the 24-hour movement composition among these adults. in addition, exploring different personal determinants, environmental determinants, and cardiometabolic markers will provide meaningful insights in developing an intervention.


Eligibility criteria:
inclusion criteria owob group * adults aged 25-64 years * active on the job market for at least 50 percent * bmi ≥25kg/m² and waist circumference c ≥94cm for men and ≥80 cm for women inclusion criteria nw participants * adults aged 25-64 years * active on the job market for at least 50 percent * bmi \<25kg/m² and waist circumference \<94cm for men and \<80 cm for women exclusion criteria nw, ow, ob patients * retirement and early retirement * unemployment * working for less than 50 percent * working in night shifts * physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis), cognitive (e.g. dementia, psychological disorders) and major medical (e.g. chronic respiratory diseases, heart failure, cardiovascular diseases) conditions that obstruct daily functioning * taking diabetes related medication * active treatment for cancer * pregnancy * breastfeeding * pregnancy \<1 year ago * currently involved in study specific weight loss interventions * waitlist for weight loss surgery * weight loss surgery \<1 year ago * taking medication which affects your body weight (e.g. thyroid medication, psychotropic medication) * thyroid problems which affects your body weight * hospitalized

Keywords: physical activity sedentary behavior sleep 24-hour movement behaviors
study of the predictive and prognostic role of pharmacogenetic and radiogenic variants on the response to neoadjuvant chemoradiation therapy in patients with locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: in locally advanced rectal cancer the pathological complete response (pcr) to neoadjuvant chemoradiation therapy (ncrt) is associated with a favourable long-term prognosis. the identification of markers predictive of response to therapy would therefore optimise treatment by allowing personalised therapy. it has been shown that the genetic profile of the patient could influence the activation of the immune system in combination with chemoradiation therapy in targeting tumour cells. in addition, genetic features of molecular pathways correlated with response to chemoradiotherapy, may in turn affect the probability of a good response to treatment in these patients, but also the occurrence of adverse events. the main objective of the study is to define the role of genetic markers related to immune system activation and other molecular pathways in predicting the complete pathological response to preoperative chemoradiation therapy in patients with locally advanced rectal cancer.


Eligibility criteria:
eligibility criteria: 1. histologically confirmed diagnosis of primary resectable larc; 2. confirmed absence of distant metastases; 3. ≥18 years old; 4. stage of disease t3-t4 and n0-n2; 5. performance status (world health organisation) 0-2; 6. normal bone marrow, kidney and liver function; exclusion criteria: 1. evidence of secondary tumour 2. inadequate liver function (bilirubin \>1.5 times the normal range, alt and ast \>2 times the normal range); 3. inadequate renal function (creatinine \>1.5 times the upper limit of normal range); 4. major concomitant systemic diseases that contraindicate surgery; 5. significant cardiovascular disease (heart failure, acute myocardial infarction within the last year, active angina, cardiac arrhythmia to be treated, uncontrolled hypertension) 6. systemic disease contraindicating radiotherapy
therapy of relapsed aml with chemotherapy and dendritic cell activated lymphocytes

Conditions: Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia

Summary: 1. determine the feasibility of generation of autologous acute myelogenous leukemia (aml) or chronic myelogenous leukemia in myeloid blast crisis (cml/bc) derived dendritic cell activated lymphocytes (dc/al) in poor prognosis patients. 2. determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes (dc/al) in patients with aml or cml/bc. 3. quantitate circulating immune effector cells in patients after infusion of dc/al. 4. record the efficacy of aml or cml/bc derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with aml or cml/bc.

most patients relapsing with aml either fail to achieve second remission or have only brief remissions. patients more than 60 years of age or having histories of antecedent hematological disorders, prior chemotherapy, or poor risk cytogenetics have generally only short remissions and as a group have two year survivals of less than 10%. equally patients with myeloid blast crisis of cml often fail to achieve remission or have responses of only brief duration. laboratory studies have shown that aml leukemic blasts may be induced in culture to differentiate into dendritic cells which in turn may be used activate autologous lymphocytes to acquire leukemia specific cytotoxicity. this trial will assess the feasibility of generation of dendritic cell activated lymphocytes, and toxicity and efficacy of these activated cells given after reinduction chemotherapy. before this study begins some toxicity information will have been generated in a trial of similar cells given to cml patients.

Eligibility criteria:
inclusion: * aml patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) wbc \> 50,000, or c) age \> 60 years\*. * aml patients are eligible for cell collection if they have \> 1000 circulating blasts/mm at diagnosis. * cml patients in myeloid blast crisis with \> 1000 circulating blasts/mm. * creatinine \<2, bilirubin \<3. * age \>18. exclusion: * factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure. * concurrent or expected need for therapy with corticosteroids. * positive antibody to human immunodeficiency virus i. * acute promyelocytic leukemia (fab-m3). * history of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy. * patients \>60 will be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.

Keywords: aml cml dendritic cells
post-frontline sequential treatment of adult philadelphia chromosome-positive acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: the primary objective of the present study is to evaluate the long-term observation, in terms of overall survival, of adult ph+ all patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to gimema protocol lal2116.

since the treatment after dasatinib and blinatumomab is not uniform and highly dependent on medical decisions, the primary aim of this ancillary trial is to evaluate the long-term follow-up of patients enrolled in the gimema 2116, in terms of overall survival (os). furthermore, the secondary objectives are the collection of data and survival outcomes relative to the therapeutic choices carried out after dasatinib and blinatumomab (i.e. allo-sct, autologous transplant, tki maintenance, etc), duration of cmr, dfs, long-term safety profile. a correlation of survival outcomes (os, dfs, etc) with the clinical and biological findings will be carried out with data collected at diagnosis and during the follow-up within the lal2116 trial.

Eligibility criteria:
inclusion criteria: * study lal2217 informed consent signature. * patients enrolled in the gimema lal2116 protocol and who have completed the 12 months follow-up

Keywords: acute lymphoblastic leukemia adult dasatinib blinatumomab lal2116